This blog began in 2007, focusing on anthrax vaccine, and later expanded to other public health and political issues. The blog links to media reports, medical literature, official documents and other materials.

Thursday, June 22, 2017

Here is a very good start at diagnosing inherent problems in the medical research enterprise, and suggestions for correcting them.--MerylBMJ2017; 357doi: https://doi.org/10.1136/bmj.j2973(Published 20 June 2017)

A response to systematic bias, wastage, error, and fraud in research underpinning patient care

Informed decision making requires clinicians and patients to identify and integrate relevant evidence. But with the questionable integrity of much of today’s evidence, the lack of research answering questions that matter to patients, and the lack of evidence to inform shared decision how are they expected to do this?

Too many research studies are poorly designed or executed. Too much of the resulting research evidence is withheld or disseminated piecemeal.1 As the volume of clinical research activity has grown2 the quality of evidence has often worsened,3 which has compromised the ability of all health professionals to provide affordable, effective, high value care for patients.”

The BMJ and the University of Oxford’s Centre for Evidence Based Medicine have collaborated on Evidence Live, a yearly conference designed to “develop, disseminate, and implement better evidence for better healthcare.” Through this work and other projects, we know of substantial problems but also progress and solutions spanning the breadth of the evidence ecosystem, from basic research to implementation in clinical practice.

The EBM manifesto offered here grew from that awareness. It is an open invitation for others to contribute to and join a movement towards better evidence by providing a roadmap for how to achieve the listed priorities and to share the lessons from achievements already made. Its aim is to complement and unite existing efforts as well as create new ones.

Why can’t we trust the evidence?

Serious systematic bias, error, and waste of medical research are also well documented (box 1).4 Most published research is misleading to at least some degree, impairing the implementation and uptake of research findings into practice. Lack of uptake into practice is compounded by poorly managed commercial and academic vested interests15; bias in the research agenda (often because of the failure to take account of the patient perspective in research questions and outcomes)1617; poorly designed trials with a lack of transparency and independent scrutiny that fail to follow their protocol18 or stop early19; ghost authorship20; publication and reporting biases5721; and results that are overinterpreted or misused,22 contain uncorrected errors,14 or hide undetected fraud.923

Box 1: Problems with current evidence

A landmark review suggested that results from half of all trials are never published, and that positive trials are twice as likely to be published as results from negative trials5

The cost of clinical drug trials rose fivefold in one decade and is hindering the development of new medicines6

A 2012 survey of 9036 BMJ authors and reviewers found that of the 2782 (31%) who replied, 13% had witnessed or had firsthand knowledge of UK based scientists or doctors inappropriately adjusting, altering, or fabricating data during their research for the purpose of publication12

8% of authors from 630 articles admitted they had lied in their authorship statements13

Poor evidence leads to poor clinical decisions. A host of organisations has sprung up to help clinicians interpret published evidence and offer advice on how they should act. These too are beset with problems such as production of untrustworthy guidelines,10 regulatory failings,23 and delays in the withdrawal of harmful drugs.24 Collectively these failings contribute to escalating costs of treatment,25 medical excess (including the related concepts of medicalisation, overdiagnosis, and overtreatment)26 and avoidable harm.24

Developing more trustworthy evidence: the EBM manifesto

The steps required to develop trustworthy evidence (box 2) have been refined through a series of activities with stakeholders, including seminars, round table discussions, online consultations, and direct feedback. Tackling the problems will take time, resources, and effort. The evidence based medicine community should take responsibility for this. However, it is a vast project that is being led, and will be led, by disparate groups around the world. We hope to focus attention on the tools and strategies most effective at delivering change, so that we can all work together to improve healthcare using better quality evidence. The manifesto document and priorities are a living document and will evolve over time to advocate for trusted evidence for better healthcare. If you want to have your say and join the discussion then visit (http://evidencelive.org/manifesto/).

Box 2: EBM manifesto for better health

Expand the role of patients, health professionals, and policy makers in research

Increase the systematic use of existing evidence

Make research evidence relevant, replicable, and accessible to end users

Reduce questionable research practices, bias, and conflicts of interests

Ensure drug and device regulation is robust, transparent, and independent

Produce better usable clinical guidelines

Support innovation, quality improvement, and safety through the better use of real world data

Educate professionals, policy makers, and the public in evidence based healthcare to make an informed choice

I have followed the 'anthrax letters' saga fairly carefully over the years (which is why I originally began to read your blog) but these two comments contained information and speculation that was new to me. The author provides several clues as to his identity so you may well be able to work out who he is (and judge what he says accordingly).

After swimming with dolphins at Key Largo, they checked me out at the edge of the pool

Visiting a Bhutanese Dzong, the regional seat of both government and religion (and a fort for good measure)

Why am I blogging?

Because life is meant to be lived! The left side of this blog has photos of some peak experiences. And the right side contains information about which I am passionate.

Too many peoples' lives are characterized by lack of authenticity, and fear of acknowledging and expressing their true nature. Employees cannot say what they think at work, and in the corporate system we must squish ourselves into square holes when we are round pegs. We thus lose touch with our souls, becoming cogs in a soulless, profit-driven machine.

The culture of political correctness has meant, in medicine, that we ignore how the foundations of our science are being undermined by commercialism. Clinical data generated or presented by the manufacturers of drugs, vaccines and devices cannot be trusted: there are hundreds of studies proving this. But this fraudulent information continues to be the only data informing the approval of vaccines, drugs and devices.

Unless scrupulous ethical conduct is demanded of physicians and biological scientists, our lack of meaningful standards will carry the medical-pharmaceutical system down the path of increasing irrelevance.

Medicine and its tools need to be affordable. The current medical-industrial milieu, characterized by contempt for science, countless ways for insiders to achieve wealth due to failure of good governance, and regulatory agency-to-industry revolving doors, has ushered in stratospheric pricing... further kicking us down that path to irrelevance.

Why is our new health care plan a giveaway to health industries instead of to health consumers? Why won't it cover all Americans? Why was the "public option" never an option for the Obama administration? Why did the promised Trump health plan evaporate the moment he was elected?

So many of our leaders carry a heavy burden of mendacity and avarice. If they instead got in touch with their own souls (perhaps by exposure to the natural world), or made their decisions by maximizing the amount of good that results, our leaders might find real meaning and value in their lives.

Until that happens, the only way to straighten out the current mess is to demand accountability and impose penalties on unethical/dishonest leaders. Both political parties enjoy bounteous hors d'oeuvres from Pharma's table, making it unlikely the existing political "process" will provide relief--as we've seen in the demoralizing healthcare reform drama.

Until then, I'll continue to "call it as I see it" in this blog -- working and living the way life should be, in rural Maine, far from the centers of power.

Ellen Byrne has created several designs encapsulating aspects of the FBI's ridiculous case against Bruce Ivins. They can be purchased on T-shirts and coffee mugs. All proceeds will be donated to the the Frederick County chapter of the American Red Cross, a favored charity of Dr. Bruce Ivins.